Clinical trials: Drug-Resistant Epilepsy
Seizures
Cannabidiol Oral Solution in Pediatric Participants With Treatment-resistant Seizure Disorders
This is a Phase 1/2, open-label trial designed to assess the pharmacokinetics, safety, tolerability, and preliminary efficacy of 3 multiple ascending doses of Cannabidiol Oral Solution in a sequential fashion.
- Trial name
- NCT02324673
- Testing
- Cannabidiol Oral Solution
- Where
- 10 sites in United States
- Volunteers
- 61 people
- Sponsor
- INSYS Therapeutics Inc
Refractory Epilepsy
Deep Brain Stimulation of the Anterior Nucleus of the Thalamus in Refractory Epilepsy
Evaluate the long-term clinical effectiveness and safety of the PINS Deep Brain Stimulation to patients with refractory epilepsy.
- Trial name
- ANT-DBS-RE (NCT02602899)
- Testing
- PINS'Deep Brain Stimulator device
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Beijing Pins Medical Co., Ltd
Epilepsy, Temporal Lobe, Drug Resistant Epilepsy
Evaluation of the NaviFUS System in Drug Resistant Epilepsy
Participants with drug-resistant epilepsy (DRE) enrolled in this study will receive focused ultrasound (FUS) treatment with the NaviFUS System, guided by the neuronavigation system to evaluate the safety and efficacy of using…
- Trial name
- NCT05947656
- Testing
- NaviFUS System
- Where
- Australia
- Volunteers
- 18 people
- Sponsor
- Genovate-NaviFUS (Australia) Pty Ltd.
Drug Resistant Epilepsy, Epilepsy
A Safety, Tolerability, and Preliminary Efficacy of Low-intensity Focused Ultrasound Neuromodulation in Patients With Drug-resistant Epilepsy
This will be a prospective, open-label, single-arm, multi-center, pilot study to evaluate the safety, tolerability, and preliminary efficacy of low-intensity focused ultrasound (LIFU) neuromodulation using NaviFUS System in…
- Conditions
- Drug Resistant Epilepsy, Epilepsy, Seizures, Focal, Seizure
- Trial name
- NCT06388707
- Testing
- NaviFUS System
- Where
- 3 sites in United States
- Volunteers
- 8 people
- Sponsor
- NaviFUS Corporation
Epilepsy
Assessment of the Efficacy and Safety of 2 Doses of Retigabine Immediate Release (900 mg/Day and 600 mg/Day) Used as Adjunctive Therapy in Adult Asian Subjects With Drug-resistant Partial-onset Seizures
The immediate release (IR) formulation of retigabine has been shown to be superior to placebo as adjunctive therapy in 3 adequate and well-controlled studies in subjects with drug-resistant partial-onset seizures (POS) who had…
- Trial name
- NCT01648101
- Testing
- Retigabine 900mg/day, Retigabine 600mg/day
- Where
- 41 sites in Hong Kong, Malaysia and 5 more
- Volunteers
- 76 people
- Sponsor
- GlaxoSmithKline
Refractory Epilepsy
Bioavailability, Safety and Tolerability of Diazepam Nasal Spray Versus Diazepam Rectal Gel (Diastat®)
This is a multi-center, open-label, crossover, pharmacokinetic, bio-availability study involving adolescents and adults with refractory (drug-resistant) epilepsy.
- Trial name
- NCT02474407
- Testing
- diazepam nasal spray, diazepam rectal gel
- Where
- 22 sites in United States
- Volunteers
- 78 people
- Sponsor
- Acorda Therapeutics
Refractory Epilepsy
Trial to Evaluate the Safety and Effectiveness of Vagus Nerve Stimulation for Children With Refractory Epilepsy
Children with refractory epilepsy who are candidates for a treatment with vagus nerve stimulation will be prospectively randomized into 2 arms.
- Trial name
- NCT03062514
- Testing
- PINS Vagus Nerve Stimualtor
- Where
- China
- Volunteers
- 84 people
- Sponsor
- Beijing Pins Medical Co., Ltd
Dravet Syndrome
Cannabidiol Oral Solution as an Adjunctive Therapy for Treatment of Participants With Inadequately Controlled Dravet Syndrome
This Phase 3 study will enroll participants diagnosed with Dravet Syndrome (DS) who are still experiencing at least one tonic-clonic, clonic, and/or focal seizures with motor components (FSMC) per week, despite ongoing treatment…
- Trial name
- NCT02318563
- Testing
- Cannabidiol Oral Solution
- Sponsor
- INSYS Therapeutics Inc
Seizures
Cannabidiol Oral Solution as an Adjunctive Treatment for Treatment-resistant Seizure Disorder
This is a multicenter, open-label trial to assess the long-term safety and efficacy of Cannabidiol Oral Solution as adjunctive therapy for pediatric participants with treatment-resistant seizure disorders, including…
- Trial name
- NCT02318602
- Testing
- Cannabidiol Oral Solution
- Where
- 11 sites in United States
- Volunteers
- 52 people
- Sponsor
- INSYS Therapeutics Inc
Drug Resistant Partial Onset Seizure
Phase 3 Study of Adjunctive Ganaxolone in Adults With Drug-resistant Partial Onset Seizures and Open-label Extension
The study will evaluate the effectiveness and safety of an investigational drug-ganaxolone - on partial seizure frequency in adults with epilepsy taking a maximum of 3 antiepileptic medications (AEDs).
- Trial name
- NCT01963208
- Testing
- ganaxolone
- Where
- 71 sites in United States, Australia and 4 more
- Volunteers
- 405 people
- Sponsor
- Marinus Pharmaceuticals
Mesial Temporal Lobe Epilepsy
Study of NRTX-1001 Neural Cell Therapy in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (EPIC (EPIlepsy Cell Therapy))
This clinical trial is designed to test whether a single image-guided intracerebral administration of inhibitory nerve cells, called interneurons (NRTX-1001), into subjects with drug-resistant unilateral mesial temporal lobe…
- Trial name
- EPIC (NCT05135091)
- Testing
- NRTX-1001
- Where
- 36 sites in United States
- Volunteers
- 88 people
- Sponsor
- Neurona Therapeutics
Drug Resistant Epilepsy, Seizure
NaviFUS™ System Neuromodulating Treatment for Patients With Drug Resistant Epilepsy
To evaluate the safety and efficacy of using NaviFUS™ system in patients with drug resistant epilepsy
- Conditions
- Drug Resistant Epilepsy, Seizure, Seizure Disorder, Epilepsy
- Trial name
- NCT04999046
- Testing
- NaviFUS System
- Where
- Taiwan
- Volunteers
- 12 people
- Sponsor
- NaviFUS Corporation
Drug-resistant Epilepsy, Focal-Onset Seizures
Study to Test the Efficacy and Safety of Padsevonil as Adjunctive Treatment of Focal-onset Seizures in Adults With Drug-resistant Epilepsy
The purpose of the study is to characterize the dose-response relationship with respect to efficacy of Padsevonil administered concomitantly with up to 3 anti-epileptic drugs (AEDs) for treatment of observable focal-onset…
- Trial name
- ARISE (NCT03373383)
- Testing
- Padsevonil
- Where
- 148 sites in United States, Australia and 17 more
- Volunteers
- 411 people
- Sponsor
- UCB Biopharma S.P.R.L.
Focal Epilepsy
A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy
The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.
- Trial name
- RISE 2 (NCT06132893)
- Testing
- BHV-7000
- Where
- 104 sites in United States, Argentina and 10 more
- Volunteers
- 390 people
- Sponsor
- Biohaven Therapeutics Ltd.
Drug Resistant Partial Onset Seizure
A Two-year Open-label Extension Study of Ganaxolone in Patients With Drug-resistant Partial-onset Seizures
A follow-on, two-year open-label extension study of ganaxolone as add-on therapy in adult patients with drug-resistant partial-onset seizures
- Trial name
- NCT02519439
- Testing
- ganaxolone
- Where
- 5 sites in United States
- Volunteers
- 26 people
- Sponsor
- Marinus Pharmaceuticals
Epilepsy, Partial
An Observational Study to Assess the Burden of Drug-resistant Partial Epilepsy in Italy
observational, non-interventional study in 120 patients with drug-resistant partial epilepsy, comprising two phases: a 3-month retrospective and a 6-month prospective.
- Trial name
- NCT01332539
- Testing
- no intervention
- Volunteers
- 240 people
- Sponsor
- GlaxoSmithKline
Seizures
A Trial of the Efficacy and Safety of CVL-865 as Adjunctive Therapy in the Treatment of Focal Onset Seizures
The goal of this clinical trial is to learn if CVL-865, when taken regularly with other anti-seizure medicines, works to prevent seizures in adults with drug-resistant focal onset seizures.
- Trial name
- NCT04244175
- Testing
- CVL-865
- Where
- 76 sites in United States, Australia and 5 more
- Volunteers
- 154 people
- Sponsor
- AbbVie
Drug Resistant Epilepsy, Focal Seizure
Safety, Tolerability, and Pharmacokinetics (PK) of Single and Multiple Ascending Oral Doses of iQ-007
This is a randomized, double-blind, placebo-controlled study conducted in healthy adult volunteers to assess the safety, tolerability and pharmacokinetics of iQ-007.
- Trial name
- NCT06899230
- Testing
- iQ-007
- Where
- Australia
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- iQure Australia Pty Ltd
Drug Resistant Epilepsy, Ketogenic Dieting
Management of Drug-resistant Epilepsy in Infants and Children: a Real-life Study of the Use of the Ketogenic Diet in France and the KetoCal® Range in Its Maintenance
This is a multicenter, prospective, observational, longitudinal study designed to describe the therapeutic value of the KetoCal® range in the maintenance of a ketogenic diet during the management of infants (from 5 months) and…
- Trial name
- KEOPS (NCT06075485)
- Testing
- Ketocal
- Where
- France
- Volunteers
- 133 people
- Sponsor
- Nutricia Nutrition Clinique
Drug Resistant Epilepsy, Autism Spectrum Disorder
Effectiveness and Impact on the Quality of Life of Ketogenic Diet in Pediatric Patients
The goal of this observational study is to learn about the clinical and nutritional effectiveness of ketogenic diet (KD) in pediatric patients with genetic, neurological or metabolic conditions requiring KD.
- Conditions
- Drug Resistant Epilepsy, Autism Spectrum Disorder, Chronic Migraine, Brain Tumor, Pediatric
- Trial name
- NCT06309251
- Testing
- ketogenic diet (as per clinical practice)
- Where
- 3 sites in Italy
- Volunteers
- 100 people
- Sponsor
- Danone Nutricia SpA Società Benefit